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510(k) Data Aggregation
(24 days)
ULTRATEMP FIRM, FAST AND REGULAR SET
UltraTemp Firm, Fast and Regular is a non-eugenol temporary cement indicated for interim cementation of inlays, crowns and bridges. It is methacrylate based and does not negatively affect resin bonding. Being water soluble until set, it cleans up easily.
UltraTemp Firm, Regular and Fast are non-eugenol temporary cements. They are methacrylate based and do not negatively affect resin bonding. Being water soluble until set, they clean up easily. UltraTemp Firm is available in regular and fast set.
This 510(k) summary (K080768) describes the device "UltraTemp Firm, Fast and Regular," which is a temporary dental cement. The submission aims to demonstrate substantial equivalence to a predicate device, UltraTemp (K994261). The testing described in this document is primarily focused on demonstrating the safety and effectiveness of the new device through product specifications and biocompatibility testing, rather than a clinical study comparing its performance against specific acceptance criteria in a real-world scenario.
Here's an breakdown of the requested information based on the provided text, with many points marked as "Not Applicable" or "Not Provided" due to the nature of this particular 510(k) submission for a dental cement:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of quantitative performance metrics for the cement (e.g., bond strength, setting time ranges) against the predicate device in a comparative table. Instead, the comparison is at a higher, qualitative level, focusing on intended use, material type, characteristics, human factors, and biocompatibility/safety.
| Property | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate (Temporary cement) | Same: "Temporary cement" and "For temporary application of provisional crowns, bridges, inlays, and onlays." |
| Characteristics | Same as predicate (Temporary Luting/Filling Material) | Same: "Temporary Luting/Filling Material" |
| Biocompatibility/Safety | Pass biocompatibility tests. Safe when used as directed. | Same: "Cytotoxicity, Sensitization, irritation and Genotoxicity testing passed. Literature and testing to demonstrate product is safe when used as directed." The new device states, "The results of biocompatibility testing demonstrate that UltraTemp Firm, Fast and Regular are safe and effective when used according to the Instructions for Use." |
| Material (Type) | Acceptable material for temporary dental cement (Methacrylate) | Different from Predicate: Predicate is Polycarboxylate; New device is Methacrylate-based. This is noted as a technological characteristic but implied to be acceptable. |
| Human Factors (Delivery) | Acceptable delivery system | Different from Predicate: Predicate is "Dual Spense Delivery System"; New device is "Double Barrel Delivery System." This is noted but implied to be acceptable. |
| Water Solubility (before set) | Cleans up easily before setting | Claimed: "Being water soluble until set, they clean up easily." |
| Resin Bonding Effect | Does not negatively affect resin bonding | Claimed: "does not negatively affect resin bonding." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly provided for any specific performance testing beyond general statements about "each lot of product." The biocompatibility testing implies biological samples were used, but the quantity of samples or subjects is not mentioned.
- Data Provenance: The testing is internal to the manufacturer, Ultradent Products, Inc. "Each lot of product must pass internal test specifications prior to release." The document does not specify country of origin for data; it's likely internal laboratory data. It is a prospective testing of manufacturing lots and biocompatibility, not analysis of pre-existing patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for this device's performance would be derived from laboratory tests and established biocompatibility standards, not from expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. This type of submission for a dental cement does not involve adjudication of clinical cases or expert readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental cement, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental cement, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Laboratory-measured physical and chemical properties: Ensuring the cement meets internal specifications for its intended function (though specific criteria and results are not detailed).
- Biocompatibility standards: Confirmation that the material passes established tests for cytotoxicity, sensitization, irritation, and genotoxicity, indicating it is safe for biological contact.
- Predicate Device Comparison: The ultimate "ground truth" for regulatory approval here is demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device based on its intended use, technological characteristics, and safety/effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (dental cement), not a machine learning model, so there is no training set in the AI context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, this question does not apply.
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